Events

X-ray system mobile arches in C 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1706-243
  • 사례 연번
    2009EBC-0003260
  • 날짜
    2017-05-22
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=86
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고

Device

X-ray system mobile arches in C
  • 모델명 / 제조번호(시리얼번호)
    ELITE, distributed between October 27, 2016 and March 28, 2017
  • 제품 설명
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operating table or examination, based on x-ray technology that allows: obtaining and / or recording of still images (conventional radiography and digital) of internal body structures by exposing a part of the body to a small dose of x-ray radiation; obtaining and / or recording moving images in real time (continuous, pulse or snapshot fluoroscopy) and video lattice of internal structures of the patient as support for diagnostic procedures, surgical procedures and intervention. These equipments are designed for anatomical visual structures converting a x radiation pattern into a visible image through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, vascular and cardiac neurology, including the implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, angiography of blood vessels, legs, heart and brain, and can be used for other imaging applications at the discretion of the doctor.
  • Manufacturer
    Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh

Manufacturer

Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipament...